JAMA article says TAXUS(R) stents superior to brachytherapy in the treatment of in-stent restenosis
15 März 2006 - 6:05PM
PR Newswire (US)
VANCOUVER, March 15 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP) today announced
along with its corporate partner Boston Scientific Corporation
("BSC") that they welcomed an article in the Journal of the
American Medical Association (JAMA) on the TAXUS V ISR (in-stent
restenosis) clinical trial that found the TAXUS(R) Express2(TM)
paclitaxel-eluting stent system achieved superior outcomes in the
treatment of in-stent restenosis compared to those patients treated
with radiation-based brachytherapy. The results of the study were
published in today's edition of JAMA. The study (TAXUS V ISR)
showed that compared with brachytherapy, implantation of
paclitaxel-eluting stents reduced the nine-month rate of target
vessel revascularization (the need for a repeat procedure in the
stented area) from 17.5 percent to 10.5 percent and target lesion
revascularization rate from 13.9 percent to 6.3 percent. The study
also demonstrated an 11.5 percent rate of Major Adverse Cardiac
Events (MACE) for the TAXUS stent group, as compared to a 20.1
percent rate for the control group. "The results from this trial in
concert with other studies, indicate that drug-eluting stents
should now be considered the treatment of choice for most patients
with ISR of previously implanted bare-metal stents. Paclitaxel-
eluting stents significantly reduce clinical and angiographic
restenosis and improve event-free survival compared with
beta-source intracoronary radiation. For patients with bare-metal
stents who develop in-stent restenosis, the availability of
drug-eluting stents represents a safe therapy resulting in a high
rate of nine-month event-free survival, a reassuring option for an
otherwise difficult-to-treat cohort of patients. Further studies
are required to demonstrate the long-term safety and durability of
this approach," the authors conclude. The study included 396
patients at 37 sites in the United States and was designed to
assess the TAXUS stent slow-release formulation paclitaxel-eluting
coronary stent system in reducing in-stent restenosis (the regrowth
of diseased tissue into a previously stented artery) versus
intracoronary brachytherapy (radiation delivered directly to the
lesion). An additional 25 patients were enrolled in a registry arm.
It had a primary endpoint of nine- month target vessel
revascularization. The diabetic sub-population analysis
demonstrated positive results, showing an overall TAXUS-related
major cardiac event rate of 3.3 percent and a re-intervention rate
of 1.9 percent. Diabetic patients are generally considered more
likely than non-diabetic patients to require repeat procedures due
to a higher incidence of restenosis following angioplasty and
stenting. CAUTION - The TAXUS(R) Express2(TM) paclitaxel-eluting
stent system is considered investigational in the United States for
use in treating in-stent restenosis and for this indication is
limited by Federal Law to investigational use only. BSC acquired
worldwide exclusive rights from Angiotech to use paclitaxel to coat
its coronary stent products and has co-exclusive rights to other
vascular and non-vascular products. About Angiotech Pharmaceuticals
Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty
pharmaceutical company pioneering the combination of pharmaceutical
compounds with medical devices and biomaterials to both create
novel solutions for poorly addressed disease states and improve
surgical outcomes. To find out more about Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please
visit our website at http://www.angiotech.com/. Statements
contained herein that are not based on historical or current fact,
including without limitation statements containing the words
"anticipates," "believes," "may," "continue," "estimate,"
"expects," and "will" and words of similar import, constitute
"forward-looking statements" within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. Such factors include, among others, the following:
general economic and business conditions, both nationally and in
the regions in which the Company operates; technology changes;
competition; changes in business strategy or development plans; the
ability to attract and retain qualified personnel; existing
governmental regulations and changes in, or the failure to comply
with, governmental regulations; liability and other claims asserted
against the Company; and other factors referenced in the Company's
filings with the United States Securities and Exchange Commission
or the Canadian securities regulators. Given these uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements. The Company does not assume the
obligation to update any forward-looking statements. FOR ADDITIONAL
INFORMATION: Analysts and Investors: Rui Avelar, Chief Medical
Officer Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext 6933
Media: Colleen Beauregard Waggener Edstrom Bioscience (503)
443-7863, Email: DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: Analysts and Investors: Rui Avelar, Chief Medical Officer,
Angiotech Pharmaceuticals, Inc., (604) 221-7676 ext 6933; Media:
Colleen Beauregard, Waggener Edstrom Bioscience, (503) 443-7863,
Email:
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